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5-year European Clinical Study shows more than 90% Patient and Physician
Satisfaction
COPENHAGEN, Denmark, May 5 /PRNewswire/ -- Contura International A/S today announced that 5-year clinical data for its soft volume filler Aquamid(R) was presented at the annual meeting for the American Society of Aesthetic Plastic Surgery (ASAPS) in San Diego. Aquamid(R) is used to rejuvenate or contour the face, either by restoring lost volume or by adding extra volume where needed. Contura is currently conducting a multicenter, comparative clinical trial of Aquamid(R) in the United States.
The 5-year study presented at the ASAPS meeting is a multicenter, prospective study of safety and long-term aesthetic results of Aquamid(R) injections for facial soft tissue augmentation and facial contouring. A total of 116 patients attended the clinics for follow-up five years after their first Aquamid(R) injection. The aesthetic outcome of injections with the Aquamid(R) hydrogel showed that 96% of the 116 patients evaluated after five years had "very good" or "good" aesthetic results according to the physician investigators and 92% of the patients were "very satisfied" or "satisfied". The safety data in the trial showed that injection of Aquamid(R) over a period of 5 years was safe with few and no unexpected adverse events. The 5-year results are consistent with the data from the 1-year, 2-year and 3- to 4-year follow-up visits.
"We are excited that our European 5-year clinical data demonstrates the long-term efficacy and safety of Aquamid(R). Aquamid(R) is well positioned to meet the global consumer needs for long-lasting aesthetic treatments to restore facial volume. In 2008 we expect to complete the 12-month follow-up in our US clinical trial and look forward to submitting the data to the FDA for review," said Michael Peytz, Chief Executive Officer.
Produced using Contura's patented hydrogel technology, Aquamid(R) is
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